1. Field of the Invention
This invention relates to surgical tools and implants generally and more specifically to a modularized system for packaging, delivering, handling, sterilizing, and tracking surgical screws and similar small components.
2. Description of the Related Art
Surgeons commonly use a variety of small implantable, mechanical components to repair fractures or cuts in bone and connective tissues. For example, small self-tapping metallic screws are sometimes used, in connection with plates and other hardware, to secure scull fractures or replace bony plugs in the skull after brain surgery. Although the hardware is superficially reminiscent of that used in woodworking and other mechanical crafts, the special-purpose screws used in surgery differ in significant ways from the common craftsman's screw. Furthermore, because the surgical screws are destined to become more-or-less permanent implants in a human body, and because of the special requirements of the surgical operating room environment, special devices and methods are wanted for packaging, delivery, handling, and sterilizing surgical screws and similar small surgical components.
Implantable surgical components are typically sterilized in one of two ways: 1) the component can be sterilized by autoclaving (exposure to steam at high pressure and temperature) or, 2) the components can be sterilized prior to shipping, then shipped, stored, and handled in hermetically sealed, sterile packaging. The second method required bulky packaging and adds expense in manufacturing, storage, and shipping. Furthermore, the bulky packaging (typically sealed plastic pouches) complicates selection and manipulation of any large number of small screws: If each screw is stored packaged separately, a large number of sealed packages must be ripped open during surgery to select an appropriate screw from a range of screw sizes. The surplus screws are then contaminated and must either be sterilized and re-packed, or else discarded.
Very small screws, for example with diameters ranging from less than 1 to several millimeters, and lengths from 2 to 10 millimeters, are extremely difficult to handle, particularly when wearing latex surgical gloves. Tweezers and similar tools are clumsy and unreliable for this purpose. Fingers are too large for precise manipulation of small screws.
Small surgical screws also pose challenges because they are difficult to see clearly enough to determine exact size, even with the aid of glasses or magnifying lenses. This makes selection and sorting difficult.
In addition to the problems already mentioned, the regulatory community seems to be increasingly interested in clearly identifying each implantable component with identification markings for tracking the components in the even that a product recall is required, or for other purposes. Identification markings serve a plurality of purposes, and may (almost certainly will, in some countries) eventually become mandatory. The small size of surgical screws and similar implants does not allow for marking of lot numbers and part numbers directly on the implant in a size that is legible to the naked eye.
These problems and other problems known and unknown in the surgical arts are addressed by the present invention.